皓瑩打電話過來說她在心蓮病房有玉里轉過去的新病人,想請我協助開Abilify, 但皓瑩提到一件事,就是病人有complete AV block, 以前都沒有這樣子過,適合吃這個藥嗎?
Drugs.com的資訊如下:
Side effects:
Uncommon (0.1% to 1%): Bradycardia, hypotension, palpitations, cardiopulmonary failure, myocardial infarction, cardio-respiratory arrest, atrioventricular block...
電聯主任後,因病人長期使用Abilify 10mg hs, 主任建議給5mg hs再繼續監測EKG.
Drugs.com全文如下:
General
The most frequently reported adverse effects in adult clinical trials of the immediate-release products included nausea, vomiting, constipation, headache, dizziness, akathisia, anxiety, insomnia, and restlessness. The most common adverse reactions in pediatric clinical trials were somnolence, headache, vomiting, extrapyramidal disorder, fatigue, increased appetite, insomnia, nausea, nasopharyngitis, and weight gain.
The most commonly reported adverse reactions in clinical trials of the extended-release IM formulation included increased weight, akathisia, injection site pain, and sedation.[Ref]
Psychiatric
Very common (10% or more): Agitation (up to 19%), insomnia (up to 18%), anxiety (up to 17%), restlessness (up to 12%)
Common (1% to 10%): Insomnia, suicidal ideation
Uncommon (0.1% to 1%): Self-mutilation, aggression, loss of libido, suicide attempt, hostility, libido increased, anger, delirium, completed suicide, tic, homicidal ideation, sleep talking, bruxism, depression, psychotic disorder, hallucination, delusion, affect lability, apathy, dysphoria,
Rare (less than 0.1%): Catatonia, sleep walking, hypersexuality, panic attack
Postmarketing reports: Pathological gambling[Ref]
Nervous system
Elderly patients (mean = 84 years old) enrolled in placebo-controlled studies examining the use of aripiprazole (the active ingredient contained in Abilify) for the treatment of dementia-related psychosis showed an increased incidence of cerebrovascular side effects, e.g. stroke and transient ischemia attacks, including fatalities. The incidence of these effects may be dose related.
In a dose response analysis, somnolence including sedation was the only adverse reaction determined to have a dose response relationship in adult patients. Somnolence was reported in 12.6% of adult patients with schizophrenia receiving the 30 mg dose.
In pediatric patients 13 to 17 years of age, extrapyramidal disorder, somnolence, and tremor displayed possible dose response relationship in patients with schizophrenia, while extrapyramidal disorder, somnolence, and akathisia displayed possible dose response relationship in pediatric patients with bipolar mania.
Extrapyramidal symptoms were more prevalent with use of the extended-release IM injection compared with oral formulations (18.4% versus 11.7%). Akathisia was the most frequently observed adverse event with the extended-release IM injection; it typically starts around day 10 and lasts a median of 56 days.[Ref]
Very common (10% or more): Headache (up to 27%), akathisia (up to 25%), somnolence (up to 23%), extrapyramidal disorder (up to 20%)
Common (1% to 10%): Dizziness, sedation, tremor, drooling, dystonia, feeling jittery, disturbance in attention, abnormal coordination
Uncommon (0.1% to 1%): Speech disorder, parkinsonism, memory impairment, cogwheel rigidity, cerebrovascular accident, hypokinesia, tardive dyskinesia, hypotonia, myoclonus, hypertonia, akinesia, bradykinesia
Rare (less than 0.1%): Grand Mal convulsion, choreoathetosis, dysgeusia
Very rare (less than 0.01%): Oromandibular dystonia
Postmarketing reports: Neuroleptic malignant syndrome, serotonin syndrome, speech disorder[Ref]
Metabolic
Very common (10% or more): Increased weight (up to 17%)
Common (1% to 10%): Decreased appetite, increased appetite, blood glucose elevations
Uncommon (0.1% to 1%): Hyperlipidemia, anorexia, diabetes mellitus, hyperglycemia, hypokalemia, hyponatremia, hypoglycemia, hypertriglyceridemia, thirst
Rare (less than 0.1%): Elevated glycosylated hemoglobin, blood triglycerides decreased, blood cholesterol decreased
Very rare (less than 0.01%): Diabetic ketoacidosis
Postmarketing reports: Blood glucose fluctuations, diabetic hyperosmolar coma[Ref]
Reports of diabetes mellitus included increases in blood insulin, decreases in carbohydrate tolerance, non-insulin dependent diabetes mellitus, impaired glucose tolerance, and glycosuria.
Analysis of 13 placebo-controlled monotherapy trials in adult patients primarily with schizophrenia or bipolar disorder revealed a mean increase in fasting blood glucose of 4.4 mg/dL with a median exposure of 25 days. This was not significantly different from placebo (+2.5 mg/dL, median exposure 22 days). A pooled analysis in pediatric patients revealed a mean change in fasting glucose of 2.4 mg/dL compared with 0.1 mg/dL in placebo treated patients following 12 weeks of therapy.
Undesirable alterations in lipids have been observed in patients receiving atypical antipsychotics. Analyses of patients receiving this drug are limited due to the small number of patients who received this drug for extended periods in the clinical trials.
Weight gain has been observed in patients receiving atypical antipsychotics. Analysis of 13 placebo-controlled monotherapy trials in adult patients primarily with schizophrenia or bipolar disorder revealed a mean change in weight of +0.3 kg (n=1673) with a median exposure of 21 to 25 days compared with a decrease of 0.1 kg in placebo treated patients (n=1100). A pooled analysis in pediatric patients (10 to 17 years) revealed a mean change in weight of +5.8 kg (n=62) compared with +1.4 kg (n=13) in placebo treated patients following 12 weeks of therapy.
During clinical trials, the percentage of pediatric and adolescent patients by indication with weight gain of 7% or more of body weight compared to placebo was (5.2% vs 1.6%), (26.3% vs 7.1%), and (20% vs 7.6%), respectively for schizophrenia/bipolar mania, irritability associated with autistic disorder, and Tourette's disorder, respectively. Treatment durations were 4 to 6 weeks, 8 weeks, and 8 to 10 weeks, respectively.[Ref]
Hypersensitivity
Uncommon (0.1% to 1%): Hypersensitivity
Postmarketing reports: Allergic reactions including anaphylactic reaction, angioedema, laryngospasm, pruritus/urticaria, or oropharyngeal spasm[Ref]
Gastrointestinal
Very common (10% or more): Nausea (up to 15%), constipation (up to 11%), vomiting (up to 11%)
Common (1% to 10%): Dyspepsia, dry mouth, toothache, abdominal discomfort, stomach discomfort, salivary hypersecretion
Uncommon (0.1% to 1%): Gastroesophageal reflux disease, swollen tongue, esophagitis, tongue spasm, dry tongue, gastritis, dysphagia
Rare (less than 0.1%): Pancreatitis, abnormal feces, feces discolored, glossitis, pruritus ani, tongue discoloration[Ref]
Dermatologic
Common (1% to 10%): Rash, hyperhidrosis, seborrheic dermatitis, neurodermatitis
Uncommon (0.1% to 1%): Face edema, angioedema, pruritus, photosensitivity reaction, alopecia, acne, rosacea, eczema, skin induration, urticaria, hirsutism
Rare (less than 0.1%): Decubitus ulcer, pemphigus, psoriasis, dry skin[Ref]
Reports of rash included erythematous, exfoliative, generalized, macular, maculopapular, papular rash; acneiform, allergic, contact, exfoliative, seborrheic dermatitis, neurodermatitis, and drug eruption.[Ref]
Cardiovascular
Collective data from 17 placebo-controlled clinical studies involving the use of atypical antipsychotic agents in the elderly patient with dementia showed a risk of death 1.6 to 1.7 times greater in the drug-treated patient than in the placebo-treated patient. The average length of duration for the trials was 10 weeks with the cause of death in the majority of cases, though not all, reported as either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Although aripiprazole (the active ingredient contained in Abilify) was not included in these studies, the consistent findings across all three relevant chemical classes support the opinion that these findings are likely to be applicable to all atypical antipsychotic agents. Aripiprazole is not indicated for use in the treatment of behavioral disorders in elderly patients with dementia.[Ref]
Common (1% to 10%): Tachycardia, hypertension, chest pain, peripheral edema, ECG QT prolongation
Uncommon (0.1% to 1%): Bradycardia, hypotension, palpitations, cardiopulmonary failure, myocardial infarction, cardio-respiratory arrest, atrioventricular block, extrasystoles, sinus tachycardia, atrial fibrillation, angina pectoris, myocardial ischemia, orthostatic hypotension
Rare (less than 0.1%): Atrial flutter, supraventricular tachycardia, ventricular tachycardia, ECG T-wave abnormal
Postmarketing reports: Sudden unexplained death, cardiac arrest, Torsade de points, Ventricular arrhythmias, QT prolongation, Venous thromboembolism[Ref]
Hematologic
Neutropenia has been reported with the prolonged-release IM injection; it typically starts around day 16 and lasts a median of 18 days.[Ref]
Uncommon (0.1% to 1%): Leukopenia, neutropenia, thrombocytopenia, anemia[Ref]
Endocrine
Common (1% to 10%): Elevated blood prolactin
Uncommon (0.1% to 1%): Brest pain
Rare (less than 0.1%): Gynecomastia, early menarche[Ref]
Musculoskeletal
Common (1% to 10%): Musculoskeletal stiffness, extremity pain, myalgia, muscle spasms, arthralgia, back pain, creatine phosphokinase elevations
Uncommon (0.1% to 1%): Muscle rigidity, muscular weakness, muscle tightness, decreased mobility, muscle twitching, joint range of motion decreased, nuchal rigidity, trismus
Rare (less than 0.1%): Rhabdomyolysis[Ref]
Other
In a dose response analysis, fatigue was determined to have a dose response relationship in pediatric patients with incidences of fatigue reported at 3.8%, 22%, and 18.5% in those receiving 5 mg, 10 mg, and 15 mg respectively.[Ref]
Very common (10% or more): Fatigue (up to 17%)
Common (1% to 10%): Pain, pyrexia, asthenia
Uncommon (0.1% to 1%): Hypothermia, gait disturbance
Rare (less than 0.1%): Heat stroke, ear canal erythema, hypoacusis, vertigo positional, tinnitus
Frequency not reported: Deafness
Postmarketing reports: Drug withdrawal syndrome neonatal[Ref]
Respiratory
Common (1% to 10%): Pharyngolaryngeal pain, cough, nasopharyngitis, rhinorrhea, upper respiratory tract infection, nasal congestion, dyspnea, pneumonia aspiration[Ref]
Ocular
Common (1% to 10%): Blurred vision
Uncommon (0.1% to 1%): Photophobia, diplopia, eyelid edema, photopsia, oculogyric crisis, eye pain
Rare (less than 0.1%): eye redness, chromatopsia, conjunctivitis, eye disorder, eye movement disorder, gaze palsy, increased lacrimation[Ref]
Genitourinary
Common (1% to 10%): Dysmenorrhea, erectile dysfunction
Uncommon (0.1% to 1%): Polydipsia, anorgasmia, urinary retention, polyuria, nocturia, irregular menstruation, amenorrhea, priapism, vulvovaginal dryness
Rare (less than 0.1%): Pollakiuria, urinary incontinence[Ref]
Hepatic
Uncommon (0.1% to 1%): Hepatic enzyme increased, bilirubin increased
Rare (less than 0.1%): Hepatitis, jaundice, elevated blood lactate dehydrogenase, increased gamma-glutamyl transferase
Postmarketing reports: Hepatic failure, alkaline phosphatase elevations[Ref]
Local
Common (1% to 10%): Injection site reaction
Uncommon (0.1% to 1%): Venipuncture site bruise[Ref]
Injection site reactions were reported with the extended-release IM formulation and included pain, erythema, induration, pruritus, swelling, rash, inflammation, and hemorrhage. The mean intensity of injection pain reported with the first injection was 7.1 (visual analog scale 0=no pain to 100=unbearably painful) and 4.8 with the second injection.[Ref]
Renal
Common (1% to 10%): Blood urea increased, nephrolithiasis[Ref]
Oncologic
Rare (less than 0.1%): Oral neoplasm, skin papilloma
Frequency not reported: Basal cell carcinoma, breast fibroma, pancreatic carcinoma